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BPC-157 at PCAC: The First Chapter in a Larger Regulatory Debate Todays PCAC review of BPC-157 is only the first phase of a broader process
It is a 20 percent solution of Aminolevulinic acid(ALA), a natural substance found throughout the human body
Gastrointestinal adverse events Very common (10% or more): Diarrhea (35%), abdominal pain (21%), vomiting (21%), nausea (12%) Common (1% to 10%): Constipation, dyspepsia, gastrointestinal disorder, melena Very rare (less than 0.01%): Abdominal cramps [Ref] Nervous system Very common (10% or more): Headache (37%), dizziness (18%), paresthesia (12%) Common (1% to 10%): Hypertonia, vertigo, taste perversion Frequency not reported : Seizures (with or without pre-existing seizure activity), increase in seizure frequency and/or severity [Ref] Metabolic Very common (10% or more): Hypercalcemia (15%), hypervolemia (12%) Common (1% to 10%): Anorexia, hyperkalemia [Ref] There are reports from clinical trials of significant hypertriglyceridemia associated with high doses of levocarnitine (3 g/day) given to uremic dialysis patients
This matters for the cost landscape because small-molecule drugs are inherently less expensive to produce at scale than biologic peptides
